Senior Clinical Research Associate

🔥 0 minutes ago

🏖️ New Jersey, New York, +1 more states – Remote

🏖️ New Jersey – Remote 🗽 New York – Remote 🤠 Texas – Remote

💵 $110.5k - $138.2k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Implement and monitor clinical trials to ensure sponsor and investigator obligations are met and comply with applicable local regulations and ICH GCP guidelines • Assess qualification of investigative sites and initiate, conduct, and close clinical trials at sites • Perform site startup activities, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget and contract negotiations • Review and verify clinical trial data collected onsite or remotely • Provide regular site status information and update trial management tools • Complete monitoring activity documentation according to sponsor SOPs • Collaborate with clinical team members to resolve trial and clinical issues • Escalate site and trial issues until resolved or closed • Reconcile essential document site files • Perform source document verification and query resolution • Assess investigational product accountability, dispensation, and compliance • Verify serious adverse event reporting according to trial specifications and ICH GCP guidelines • Communicate with investigative sites and update tracking systems • Ensure required training is completed and documented • Function with little oversight at the senior level • Serve as a subject matter expert for clinical operations monitoring activities at the senior level • Work on complex studies and/or sites as assigned • Provide leadership to assigned clinical operations projects • Serve as an observation and performance visit leader • Support resolution of site issues and facilitate trial timelines across functional areas

🎯 Requirements

• Highly responsive, proactive team player • Undergraduate degree or equivalent in a clinical, science, or health-related field from an accredited institution, or licensed healthcare professional, or equivalent work experience • 2–5 years of clinical monitoring experience required for CRA 2 • 5+ years of clinical monitoring experience required for Senior CRA • Knowledge of ICH and local regulatory authority regulations regarding drugs • Fluent English reading, writing, and speaking • Oncology monitoring Phase II/III experience required • Experience serving as observation and performance visit leader • Experience with feasibility, site selection, and site startup required • Budget negotiation experience preferred • Advanced negotiating skills may be required for assigned clinical tasks • Legally authorized to work in the United States • Must not require now or in the future sponsorship for an employment visa • Required training must be completed and documented

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways • Inclusive and accessible workplace • Reasonable accommodations during the recruitment process • Sustainable business practices and support for communities